Clinical trials are conducted to collect safety and efficacy data for new drugs or devices that a company wishes to make available to the public. A typical clinical trial for a new drug is performed by having a plurality of clinical research sites administer the drug to a plurality of patients who are screened and then enrolled at the respective sites. Each site is managed by a local site clinical investigator, who is typically a physician. A principal investigator or lead investigator is in charge of the clinical trial.
A clinical data management system (CDMS) is used to manage the data of a clinical trial. The clinical trial data includes patient data collected at the investigator sites in case report forms (CRFs), also, interchangeably referred to herein as “electronic case report forms” (eCRFs), and patient data received back from patient samples sent to labs. The patient data may also be received from an interactive voice response (IVR) system, or from diagnostic tests performed at the investigator sites, such as electrocardiogram (ECG) data.
During a clinical trial, patient data is collected from a plurality of different sources. In many instances, the same data is collected from more than one source. The data from one source sometimes does not match the same data from another source. When such mismatches occur, it is necessary to reconcile the data, which typically requires human intervention. The process of identifying the mismatches and tracking the mismatches to ensure that action is taken to reconcile them is an extremely complicated task. Attempts have been made in the prior art (discussed further below) to use spreadsheets and reports to perform this task. However, these prior art attempts are not efficient and thus have not provided an acceptable solution to this problem.